Quality of Life and Humanistic Burden of Adults with Type 1 Diabetes with Recurrent Severe Hypoglycemic Events and Impaired Awareness of Hypoglycemia Using a Continuous Glucose Monitor

INTRODUCTION: This study aimed to examine psychosocial well-being, quality of life (QoL), and productivity in people with type 1 diabetes (pwT1D) who were experiencing recurrent severe hypoglycemic events (SHEs) and impaired awareness of hypoglycemia (IAH), despite using continuous glucose monitors (CGMs). METHODS: The study utilized a cross-sectional, observational design which incorporated an online survey about SHE experiences, diabetes-related complications, psychosocial burden, QoL, and productivity in a sample of adult pwT1D who use CGM in the United States. Participants completed measures of IAH status (modified Gold score ≥ 4 = IAH), diabetes distress (DDS-17), fear of hypoglycemia (HFS-II), QoL (DIDP and EQ-5D-5L), and productivity (DPM). Participants were categorized into two cohorts based on self-reported history of SHEs and IAH: the cohort of recurrent SHE [≥ 2 SHEs in the past 12 months] with IAH, and the cohort of No SHE and No IAH to provide context. Unadjusted comparisons (Welch's t test, Pearson's chi-squared test) were conducted to describe differences across cohorts. RESULTS: In this US study population of adult CGM users, the recurrent SHE (≥ 2) with IAH cohort included 174 participants, and the No SHE and No IAH cohort included 689 participants. On average, participants with recurrent SHEs and IAH reported 8.6 SHEs in the past year. Compared to those with No SHE and No IAH, those with recurrent SHEs and IAH had a higher psychosocial burden (fear of hypoglycemia and diabetes distress), lower QoL, worse overall health status, and reduced productivity (all p < 0.001). CONCLUSIONS: Despite using CGM, adults with T1D with recurrent SHEs and IAH experienced lower psychosocial well-being, QoL, and reduced productivity compared to adults with T1D with no SHEs and no IAH, highlighting the unmet need for novel therapies for this group.